Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
NCT ID: NCT04533217
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2021-03-29
2026-07-31
Brief Summary
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Detailed Description
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Possible candidates will be identified at the departments of Hematology where the patients are treated for their disease. All Danish departments of Hematology will be invited to participate.
The hematologist will inform the patient of the protocol and decide if they fulfil the inclusion and exclusion criteria. If the patient wishes to participate the hematologist will fill out screening forms regarding disease stage, lines of treatment, current disease status, bisphosphonate status, and pain relief treatment. The hematologist will refer the patient to their collaborating surgical department. The surgical department will decide if the patient has contraindications for surgery and inform the patient of the risk of the procedure.
If the patient decides to participate, he or she will fill out forms regarding ODI, VAS pain score, QoL.
Before randomization, the patients will be divided into two groups, stratifying between patients with known multiple myeloma with new diagnosed spine fracture and relevant pain ≤ 3 months prior to inclusion and patients with newly diagnosed multiple myeloma with new spine fracture.
Furthermore, to ensure balanced control and intervention groups the included patients at randomization will be stratified according to 1) panned PVP of 1 vs 2-4 levels, and 2) former vertebral fractures that are not planned treated with PVP.
The patients will be randomized to either PVP treatment or conservative treatment by drawing. It is therefore not possible for patients to choose between the treatments.
Patients randomized to vertebroplasty will be referred to a facility performing vertebroplasty. Patients randomized to non-vertebroplasty will receive the departments' usual care with the option to change treatment arm after 4 weeks.
The randomization will be performed by the diagnosing clinician, but orchestrated by one individual central to the clinics. The clinics will receive sealed envelopes containing the choice of randomization equally divided between PVP and conservative treatment. When all sealed envelopes have been used for randomization, the clinics will receive new envelopes.
It will not be possible to randomize more than one patient at a time. All patients will be contacted by a research nurse on a weekly basis the first 12 weeks after enrolment and after 3 and 12 months.
All patients randomized to vertebroplasty will undergo standard operative treatment involving a standard scheduled outpatient clinical control with the surgeon 12-weeks post-operative including long-standing radiographs of the spine.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Vertebroplasty
Patients treated with vertebroplasty in addition to regular medical treatment.
Vertebroplasty
Injection of cement into vertebral lesion(s)
Regular treatment
Patients treated with regular medical treatment.
No interventions assigned to this group
Interventions
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Vertebroplasty
Injection of cement into vertebral lesion(s)
Eligibility Criteria
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Inclusion Criteria
* verified lesion(s) between Th6-L5
* 4 or less fractures
* relevant pain in 3 months or less
* vertebroplasty can be performed in one procedure
* VAS 5 or more
Exclusion Criteria
* psychological or psychiatric disorder hat is expected to interfere with compliance
18 Years
ALL
No
Sponsors
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Spine Centre of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Mikkel Andersen, Professor
Role: PRINCIPAL_INVESTIGATOR
Centre of Spine Surgery and Research, Middelfart Hospital
Locations
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Center for Spine Surgery and Research
Middelfart, Region Syddanmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Wickstroem LA, Carreon L, Lund T, Abildgaard N, Lorenzen MD, Andersen MO. Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial. BMJ Open. 2021 Sep 6;11(9):e045854. doi: 10.1136/bmjopen-2020-045854.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S-20200075
Identifier Type: -
Identifier Source: org_study_id